Investigation of the Relationship Between Taste Perception and Caries Activity in School Children

March 12, 2018 updated by: Edibe Egil, University of Beykent

Four basic taste perceptions and relationship with caries are poorly investigated in children as compared to adults.

The aim of this study was to evaluate salty, sweet, bitter and sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study design

  1. Caries risk assessment The investigators developed a questionnaire to understand the patient's overall health status, to collect demographic and socio-economic information, to assess their oral health habits. The questionnaire consists of 3 parts; first part includes questions about general health such as chronic diseases, drugs and allergies, second part includes questions about income and education level of parents, and last part includes questions about oral health knowledge, habits, diet contents and frequency, fluoride exposure. the investigators allowed the parents to fill the questionnaire.

    After the questionnaire was filled, the investigators performed the oral examination using DMFT, DMFS, dft and dfs indices according to WHO. Then, the investigators determined the oral hygiene status with Sillness&Löe Index (Silness ve Loe, 1964). the investigators estimated paraffin-stimulated salivary flow rate, buffer capacity, mutans streptococci and lactobacilli counts using CRT chairside kits (Ivoclar Vivadent, Schaan, Liechtenstein).

    In addition to initial questionnaire and oral examination, the investigators asked the patients to record their nutritional takings of 2 weekdays and 1 weekend day. the investigators estimated the caries risk profiles of all children using the Cariogram which is a computer-based program. Cariogram identifies three risk groups low, medium and high caries risk according the scores.

  2. Taste evaluation the investigators prepared aqueous basic taste solutions of sucrose (Merck, Germany, purity >99.5%), sodium chloride (Sigma-Aldrich, USA, purity >99%), caffeine (Merck, Germany, purity >99.5%), citric acid monohydrate (Sigma-Aldrich, USA, purity >99%), at two levels (1.0 ISO, 2.0 ISO) (ISO 3972:1991, 8586-1:1993) (Table 1). the investigators formulated all the solutions by using spring water in the same day of measurement at room temperature (25 ± 2°C). Each solution was coded randomly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- without any chronic disease such as diabetes and being ASA I or ASA II. We only included patients who had no antibiotics and drug intake within the last month.

Exclusion Criteria:

- chronic disease ASA III, IV antibiotic and drug intake within the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: high caries risk
children with high caries -identified by cariogram to evaluate sweet taste perception, salty taste perception, sour taste perception and bitter taste perception of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.
Other: salty taste perception

salty taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate salty taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors(high caries risk, medium caries risk, low risk ).

Other Names:
  • sodium chloride
  • Sigma-Aldrich, USA
  • RIEDEL SK.S.314
Other: bitter taste perception

bitter taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate bitter taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).

Other Names:
  • caffeine
  • Merck, Germany
  • MERCK 102584
Other: sour taste perception
sour taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
  • Sigma-Aldrich, USA
  • citric acid
  • RIEDEL SK.R.2 7102
Other: sweet taste perception

sweet taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate sweet taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).

Other Names:
  • Merck, Germany
  • sucrose
  • MERCK 1.07651.1 000
OTHER: medium caries risk
children with medium caries- identified by cariogram to evaluate sweet taste perception, salty taste perception, sour taste perception and bitter taste perception of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.
Other: salty taste perception

salty taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate salty taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors(high caries risk, medium caries risk, low risk ).

Other Names:
  • sodium chloride
  • Sigma-Aldrich, USA
  • RIEDEL SK.S.314
Other: bitter taste perception

bitter taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate bitter taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).

Other Names:
  • caffeine
  • Merck, Germany
  • MERCK 102584
Other: sour taste perception
sour taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
  • Sigma-Aldrich, USA
  • citric acid
  • RIEDEL SK.R.2 7102
Other: sweet taste perception

sweet taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate sweet taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).

Other Names:
  • Merck, Germany
  • sucrose
  • MERCK 1.07651.1 000
OTHER: low risk
no caries or low risk- identified by cariogram to evaluate sweet taste perception, salty taste perception, sour taste perception and bitter taste perception of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.
Other: salty taste perception

salty taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate salty taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors(high caries risk, medium caries risk, low risk ).

Other Names:
  • sodium chloride
  • Sigma-Aldrich, USA
  • RIEDEL SK.S.314
Other: bitter taste perception

bitter taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate bitter taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).

Other Names:
  • caffeine
  • Merck, Germany
  • MERCK 102584
Other: sour taste perception
sour taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
  • Sigma-Aldrich, USA
  • citric acid
  • RIEDEL SK.R.2 7102
Other: sweet taste perception

sweet taste perception in high caries risk, medium caries risk, low caries risk.

The aim of this study was to evaluate sweet taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).

Other Names:
  • Merck, Germany
  • sucrose
  • MERCK 1.07651.1 000

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DMFT, DMFS, dft and dfs indices
Time Frame: 1 year
DMFT, DMFS, dft and dfs indices are total counts of decayed, missing, filled teeth / DMFT, Plaque index, Salivary flow rate, buffer capacity, mutans streptococci and lactobacilli counts are combined to report caries risk in high/medium/low caries risk
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sillness&Löe Index
Time Frame: 1 year
Sillness&Löe index in total amount of dental plaque on the teeth. /DMFT, Plaque index, Salivary flow rate, buffer capacity, mutans streptococci and lactobacilli counts are combined to report caries risk in high/medium/low caries risk
1 year
Salivary flow rate
Time Frame: 1 year
Salivary flow rate in ml/minute
1 year
buffer capacity
Time Frame: 1 year
buffer capacity in pH / DMFT, Plaque index, Salivary flow rate, buffer capacity, mutans streptococci
1 year
mutans streptococci and lactobacilli counts
Time Frame: 1 year
mutans streptococci and lactobacilli counts in cfu/ml / DMFT, Plaque index, Salivary flow
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Beykent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAG-C-DRP-090414-0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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